Patent Grant
8545535
The present application is a non-provisional of, and claims the benefit of U.S. Provisional Patent Application Nos. 61/177,602, filed May 12, 2009; 61/219,290, filed Jun. 22, 2009; 61/263,728, filed Nov. 23, 2009; 61/263,751 filed Nov. 23, 2009; 61/298,780, filed Jan. 27, 2010; and 61/304,352, filed Feb. 12, 2010; the entire contents of each of the above listed patent applications is incorporated herein by reference.
The present application is also related to U.S. patent application Ser. Nos. 12/605,065, filed Oct. 23, 2009; 12/776,177, filed concurrently with the present application; and 12/776,225, also filed concurrently with the present application; each of which, the entire contents are incorporated herein by reference.
1. Field of the Invention
The present disclosure relates to medical devices, systems and methods, and more specifically to methods, systems and devices used for knotless suturing of tissue.
Soft tissue such as tendons, ligaments and cartilage are generally attached to bone by small collagenous fibers which are strong, but which nevertheless still can tear due to wear or disease. Examples of musculoskeletal disease include a torn rotator cuff as well as a torn labrum in the acetabular rim of a hip joint or the glenoid rim in a shoulder joint.
Thus, treatment of musculoskeletal disease may involve reattachment of torn ligaments, tendons or other tissue to bone. This may require the placement of devices such as suture anchors within bone. A suture anchor is a device which allows a suture to be attached to tissue such as bone. Suture anchors may include screws or other tubular fasteners which are inserted into the bone and anchored in place. After insertion of the anchor, the tissue to be repaired is captured by a suture, the suture is attached to the anchor (if not already pre-attached), tension is adjusted, and then the suture is often knotted so that the tissue is secured in a desired position.
Most conventional suture anchors require the surgeon to tie knots in the suture to secure the target tissue to the bone after the anchor is placed. Knot tying can be difficult during surgery, particularly if working in a confined space through cannulas or other surgical ports as in arthroscopic surgery. Therefore, it would be desirable to provide knotless suture anchor systems.
Additionally, many surgeons prefer to use polymeric anchors rather than metal ones so that the anchors are compatible with the use of MRI. While polymeric anchors are available, they do not have the knotless suture securing capabilities described above. This may be in part due to challenges of fabricating polymer anchors that provide a reliable cinching mechanism for a knotless anchor at the small scale required for orthopedic procedures. Further, while it is frequently advantageous to fabricate polymeric devices by molding, known knotless anchor designs require multiple moving parts and geometries which are not suitable for molding. Therefore it would be advantageous to provide a knotless anchor with the characteristics described above and which is also suitable to being molded with a polymer as a single integral part or as series of molded components that can be easily assembled together. By single integral part, it is meant that the entire part is formed from a single piece of material or molded as a single piece, without need for fastening, bonding, welding or otherwise interconnecting multiple components together. Examples of this include, but are not limited to, single-piece components that are injection molded, cast, or machined from a single block of material. The word “molded” is intended to encompass materials which are injection molded, blow molded, compression molded, thermoformed, or made using other molding processes known to those of skill in the art, useful for shaping polymers, ceramics, or other formable materials.
Frequently two or more anchors and multiple lengths of suture are required. Using such devices can be time consuming and difficult to undertake in the tight space encountered during endoscopic surgery and sometimes even in conventional open surgery. Recently, knotless suture anchors having suture clamping mechanisms have been developed to eliminate the need to tie knots but they still can be difficult or awkward to use.
Some knotless suture anchors have been devised which allow the suture to be cinched and secured without tying a knot, however these typically rely upon trapping the suture between the anchor and the bone to secure the suture, which means the anchor cannot be fully inserted into the bone until the tissue has been captured and secured tightly. The process of maintaining tension on the suture, keeping the tissue at the desired location and simultaneously inserting the anchor into the bone is difficult. Other knotless anchors rely on the manual actuation of some type of moving part on the anchor to clamp or trap the suture within the anchor, requiring an extra hand that the surgeon may not have available. It would be desirable to allow the anchor to be fully inserted in the bone prior to securing the tissue and to avoid the requirement of extra manipulations to secure the suture.
Thus, it would be desirable to provide improved knotless suture anchors that are easier to use and also that may take up less space during deployment and that are easier to deploy.
In particular, treating musculoskeletal disease in a hip joint can be especially challenging. The hip joint is a deep joint surrounded by a blanket of ligaments and tendons that cover the joint, forming a sealed capsule. The capsule is very tight thereby making it difficult to advance surgical instruments past the capsule into the joint space. Also, because the hip joint is a deep joint, delivery of surgical instruments far into the joint space while still allowing control of the working portions of the instrument from outside the body can be challenging. Additionally, the working space in the joint itself is very small and thus there is little room for repairing the joint, such as when reattaching a torn labrum to the acetabular rim. Moreover, when treating a torn labrum, the suture anchor must be small enough to be inserted into the healthy rim of bone with adequate purchase, and the anchor also must be short enough so that it does not protrude through the bone into the articular surface of the joint (e.g. the acetabulum). Existing anchors may be used to repair the labrum, but are not well-suited to labral repair especially in the hip. First, the reattachment of the labrum to the acetabular rim is most effective if both ends of the suture are attached to the same point in the bone. This provides the most precise and secure apposition of the labrum to the rim. The space available on the acetabular rim is very limited, typically requiring an anchor with a transverse dimension (e.g. diameter) preferably less than 4 mm and no more than about 3.5 mm and therefore many commercially available anchors are too large. Thus, it would be desirable to provide suture anchors that have a small diameter and length.
Additionally, existing knotless anchors are typically designed for use in rotator cuff repair in the shoulder and they are intended for placement in separate holes in the bone. These devices have no mechanism for coupling one anchor to the other within the same hole, cannot be implanted concentrically within the hole, and are too long for stacking within the same hole. Further, many existing knotless anchors are too large for placement on the acetabular rim for labral repair of the hip.
In addition, existing knotless anchors and interconnecting anchors have suture locking mechanisms which have moving parts and other complex designs that are not reliably manufacturable at the small scale required for labral repair anchors. While various types of anchors with suture locking mechanisms have been disclosed, many of these cannot be made in an anchor less than 4 mm, and no more than 3.5 mm in diameter.
Moreover, because of the difficulty of performing labral repairs arthroscopically, it is highly desirable to minimize the manipulations of the suture and anchor that are required intraoperatively. Many existing knotless anchors require the surgeon, after initial anchor placement and capture of the labrum, to thread the free end of the suture through the anchor or a component of the anchor, which is difficult and takes an excessive amount of time. Some anchors further require the surgeon to push the anchor further into bone, or push a locking mechanism on the anchor, or perform some other manipulation of the anchor in order to lock the suture. These manipulations add difficulty and time to arthroscopic labral repair that would be desirably avoided.
Therefore, it would be desirable to provide improved knotless suture anchors that are ideally suited to arthroscopic procedures, and in particular labral repair in the hip. The anchors would preferably be adapted for placement in a single hole in the bone, extremely simple in design with few or no moving parts, manufacturable at very small scale (e.g. diameter less than 4 mm, and preferably no more than 3.5 mm), and ideally be moldable as a single part or a few easily assembled parts. Further, once the suture has been tightened as desired, the anchor should automatically lock the suture in place without requiring tying or manipulation of the suture or any mechanisms on the anchor itself. The anchors should further require no intraoperative threading or tying of the suture ends before or after initial anchor placement.
Thus, there is a need for improved devices, systems and methods which overcome some of the aforementioned challenges. At least some of these objectives will be met by the inventions described hereinbelow.
2. Description of the Background Art
Patents disclosing suture anchoring devices and related technologies include U.S. Pat. Nos. 7,566,339; 7,390,329; 7,309,337; 7,144,415; 7,083,638; 6,986,781; 6,855,157; 6,770,076; 6,767,037; 6,656,183; 6,652,561; 6,066,160; 6,045,574; 5,810,848; 5,728,136; 5,702,397; 5,683,419; 5,647,874; 5,630,824; 5,601,557; 5,584,835; 5,569,306; 5,520,700; 5,486,197; 5,464,427; 5,417,691; and 5,383,905. Patent publications disclosing such devices include U.S. Patent Publication Nos. 2009/0069845 and 2008/0188854 and PCT Publication No. 2008/054814.
The present invention provides devices, systems and method for knotless suturing of tissue. Exemplary procedures where knotless suturing may be advantageous include repair of torn rotator cuffs, as well as a torn labrum in the acetabular rim of a hip joint or the glenoid rim in a shoulder joint, and also in urinary incontinence repair. The invention relates to suture anchors for anchoring sutures to bone, and more specifically provides a suture anchor which eliminates the need for knotting the suture and which is suited to being a molded polymer construction. The anchors will find particular utility in hip and shoulder arthroscopy, e.g. labral reattachment and similar procedures.
In a first aspect of the present invention a suture anchor system for securing target tissue to base tissue comprises a first anchor having a proximal end, a distal end, and a longitudinal axis therebetween. The first anchor is configured for insertion in the base tissue with an exterior thereof in engagement with the base tissue so as to resist removal of the first anchor from the base tissue. A bar is coupled to the first anchor and a suture is tied around the bar so as to form a one-way sliding knot with first and second extremities of the suture extending therefrom. The one-way sliding knot is configured to allow the suture to slide around the bar in a first direction when the first extremity is tensioned and to substantially prevent the suture from sliding around the bar in a second direction opposite the first direction when the second extremity is tensioned.
The one-way sliding knot preferably comprises a hitch having a pole portion and a loop portion wrapped around the pole portion, whereby tension on the loop portion pulls the pole portion in a direction transverse to the pole portion, increasing friction between the pole portion and the bar. Preferably the loop portion when tensioned pulls the pole portion in a direction tangential to an outer surface of the bar. In some embodiments, the loop portion pulls the pole portion into a gap disposed between the bar and a wall of the first anchor whereby the pole and loop portions are wedged between the bar and the wall. In preferred embodiments, the hitch is a munter hitch.
In a particular embodiment, the bar is coupled with the first anchor in a position spaced apart from the exterior surfaces of the first anchor which engage the base tissue to allow a suture to slide around the bar when the exterior is engaging the base tissue. The bar has an outer surface which is separated from a wall of the first anchor by a gap. The length of suture has a first extremity extending from a first side of the bar and a second extremity wrapped around the bar and looped around the first extremity to form a U-loop having first and second segments. Each of the first and second segments extend slidably through the gap, such that upon tensioning the second extremity the U-loop pulls the first extremity toward the gap. The suture is longitudinally movable in a first direction when the first extremity is tensioned and the suture is inhibited from moving in a second direction opposite the first direction when the second extremity is tensioned.
The second extremity may be wrapped back around the bar from the U-loop such that the first and second extremities extend out of the cavity from a same side of the bar. The first anchor may have a cavity with at least one opening in the proximal end, and the bar may be disposed in the cavity. The U-loop may pull the first extremity in a direction generally tangential to the outer surface of the bar. The gap may have a width which is smaller than the combined uncompressed thickness of the first and second extremities. A space may be disposed between the bar and the distal end and may be configured to allow a suture to slide through the space when the distal end is engaging tissue.
The second extremity may have a free end adapted to be coupled to the first anchor so as to form a repair loop configured to be placed around or through tissue to be secured. The system may further comprise a suture retaining structure on the first anchor for retaining the free end of the second extremity. The suture retaining structure is preferably configured to receive a free end of the second extremity such that the second extremity forms a repair loop between the hitch and the retaining structure in which to capture the target tissue. The retaining structure preferably retains the second extremity such that the free end is movable relative to the retaining structure to allow adjustment of the size of the repair loop. In preferred embodiments, with the anchor fully assembled and ready for implantation, the retaining structure is accessible from the exterior of the anchor so that the user can couple the free end with the retaining structure intraoperatively and adjust the size of the repair loop by pulling the free end relative to the anchor after the target tissue has been captured in the repair loop. This allows gross adjustment of the repair loop size and tension before or during insertion of the anchor in the base tissue. Final adjustment of the repair loop can then be performed by tensioning the first extremity when the anchor has been fully implanted in its final position.
The suture retaining structure may comprise a transverse passage through the first anchor, preferably having an opening exposed on and exterior wall of the anchor to receive the free end of the second extremity intraoperatively with the anchor in its fully assembled condition. The suture retaining structure may comprise a clamping mechanism coupled to the first anchor. The clamping mechanism may comprise a clamping member movably coupled to the first anchor. The clamping member may be movable from a first position in which the second extremity is longitudinally movable relative to the first anchor to a second position in which the clamping member engages the second extremity to inhibit its movement relative to the first anchor. The clamping member may compress the second extremity against a clamping surface on the first anchor.
The suture retaining structure may comprise a movable element coupled to the first anchor. The movable element may be movable so as to move the second extremity from a less tortuous path through the first anchor to a more tortuous path through the first anchor. The movable element may have a transverse passage through which the second extremity extends. The movable element may be disposed within an inner channel in the first anchor. The movable element may be concentrically disposed around the exterior of the first anchor. The movable element may be rotatably coupled to the first anchor or it may be threadably coupled thereto. The movable element may extend distally from a distal end of the first anchor or it may be configured to remain stationary relative to the first anchor as the first anchor is rotated.
The first anchor may have threads on an exterior thereof configured to allow the first anchor to be screwed into bone or tissue. The second extremity may form at least a first loop around the bar. The free end may be positionable between the first loop and the bar so as to be clamped therebetween. The system may further comprise a blocking structure on the first anchor adapted to prevent the U-loop from moving around the bar when the first extremity is tensioned. The first anchor may further comprise a cavity. The bar may be disposed in the cavity, and the wall may be a first wall of the cavity. The blocking structure may comprise at least a portion of the first wall disposed in a position relative to the bar which prohibits the U-loop from passing between the wall and the bar. The bar may be disposed asymmetrically within the cavity such that a second wall of the cavity is further from the bar than the first wall. The blocking structure may comprise an extension extending laterally outward from a first side of the bar. The first anchor may further comprise a cavity. The bar may be disposed in the cavity, and the blocking structure may comprise an extension extending inward from a first wall of the cavity. The anchor may further comprise a cavity having at least one opening in the proximal end and the bar is recessed within the cavity distally from the at least one opening. The bar may be spaced proximally from the distal end of the first anchor. The bar may further comprise a cavity having a distal floor. The bar may be disposed within the cavity and spaced proximally from the distal floor. The first anchor and the bar may be a unitary molded construct.
The system may further comprise a tissue retention structure on the exterior of the first anchor for retaining the first anchor in tissue or bone. The tissue retention structure may comprise a plurality of ribs, barbs, or concentric scallops. The first anchor may be configured to be hammered into bone without a pre-drilled hole. The first anchor may comprise threads on an exterior thereof for screwing the first anchor into bone. The distal end of the first anchor may comprise a pointed tissue piercing tip. The system may further comprise a second anchor member separable from the first anchor and having means for coupling to the first anchor. The first anchor and the second anchor member may be concentrically coupled together. The first anchor and the second anchor member may be coupled together end to end.
The first anchor may have a cavity having a sidewall and the bar may be asymmetrically positioned in the cavity such that the space between the bar and the sidewall is larger on a first side of the bar than on a second side of the bar. The space on the first side of the bar may be substantially larger than a cross-sectional thickness of the suture. The space on the second side of the bar may be less than the cross-sectional thickness of the suture. The space on the second side of the bar may be configured to prevent the U-loop from rotating about the bar in response to tension on the second extremity. The first anchor may further comprise a cavity and the bar may divide the cavity into first and second longitudinal channels. The first and second longitudinal channels may be interconnected by a transverse passage within the first anchor distal to the bar. The cavity may have a distal floor opposite the at least one opening. The transverse passage may comprise a space between the bar and the distal floor.
The first anchor may comprise at least one deployable retention member coupled thereto. The retention member may be movable from a first configuration in which it has a low radial profile suitable for introduction into tissue, to a second configuration in which it has a higher radial profile for engagement with tissue adjacent the first anchor. The first anchor may comprise an actuation member movable relative to the retention member from a first position in which the retention member is in the first configuration to a second position in which it engages the retention member to move it into the second configuration. The retention member may be coupled to a tubular retainer body disposed concentrically over the actuation member. The actuation member may comprise a camming element configured to engage an inner surface of the retention member to move it from the first configuration to the second configuration. The inner surface of the retention member may be sloped inwardly in the first configuration. When the anchor system has been implanted in tissue the retainer body may be configured to remain stationary in the tissue and the actuation member may be movable relative to the retainer body to move the retention member from the first to the second configuration. The actuation member may be retractable proximally relative to the retainer body. The actuation member may be fixed to the first anchor such that the first anchor is movable together with the actuation member relative to the retention member.
The system may further comprise a suture retaining structure in the first anchor for applying a retention force to a free end portion of the suture. Moving the retention member from the first configuration to the second configuration causes the suture retaining structure to increase a retention force applied to the free end portion. Movement of the retention member from the first configuration to the second configuration may move the free end portion from a less tortuous configuration to a more tortuous configuration.
The hitch may be formed around an axial axis of the bar, the axial axis being transverse to the longitudinal axis of the first anchor. Alternatively, the hitch may be formed around an axial axis of the bar, the axial axis being generally parallel to the longitudinal axis of the first anchor. The bar may be disposed within a cavity in a middle portion of the first anchor having a lateral opening on a sidewall of the first anchor. The first anchor may further include least one longitudinal channel on the sidewall of the first anchor extending from the proximal end to the lateral opening. The bar may also be coupled to a proximal end of the first anchor and spaced proximally therefrom in a handle-like or cleat-like configuration.
In another aspect of the present invention, a method of securing target tissue to base tissue comprises providing a first anchor having a bar, a suture tied around the bar to form a hitch which allows the suture to slide around the bar in a first direction and substantially prevents the suture from sliding around the bar in a second opposite direction, the suture having first and second extremities extending from the bar. The second extremity is coupled to the target tissue, and the first anchor is inserted into the base tissue. The first extremity is tensioned to slide the suture relative to the bar in a first direction whereby the target tissue is drawn toward the base tissue by the second extremity with the first extremity remaining uncoupled to the target tissue.
In preferred embodiments the hitch comprises a pole portion and a loop portion wrapped around the pole portion, whereby tension on the loop portion pulls the pole portion in a direction transverse to the pole portion, increasing friction between the pole portion and the bar. Tension on the loop portion preferably pulls the pole portion in a direction tangential to an outer surface of the bar. In some embodiments the loop portion pulls the pole portion into a gap disposed between the bar and a wall of the first anchor whereby the pole and loop portions are wedged between the bar and the wall.
The second extremity may form a U-loop around the first extremity such that tension in the second extremity causes the U-loop to pull on the first extremity in a direction generally tangential to an exterior surface of the bar so as to inhibit movement of the suture. The wrapping of the suture may comprise wrapping the suture around the bar so that the first and second extremities extend from opposite sides of the bar, and looping the second extremity around the first extremity to form the U-loop. The second extremity may be wrapped back around the bar so that both the first and second extremities extend from the same side of the bar. The first anchor may comprise a cavity having a sidewall, the bar being disposed within the cavity. A first gap may lie between the bar and sidewall. The U-loop may pull the first extremity into the first gap when the second extremity is tensioned. The first gap may have a first width which is less than the combined thickness of the first and second extremities. A second gap may lie between the bar and a second wall of the cavity. The second gap may have a second width substantially larger than the first width. The inserting step may comprise screwing the first anchor into the base tissue. The inserting may also comprise coupling an insertion tool to the first anchor, and rotating the insertion tool to screw in the anchor. The method may further comprise preventing the second extremity from wrapping around the insertion tool as it is rotated. The second extremity may be pre-wound around the insertion tool a predetermined number of winds, and the preventing step may comprise unwrapping the predetermined number of winds from the insertion tool as it is rotated.
The coupling step may comprise passing the second extremity around or through the target tissue to form a loop, further comprising retaining a free end portion of the second extremity in the suture anchor. The free end portion may be retained in the suture anchor such that it remains in a stationary position relative to the base tissue as the anchor is screwed into the base tissue. The free end portion may be retained by a retaining structure rotatably coupled to the first anchor. The method may further comprise deploying a retention element from the first anchor after the step of inserting. The first anchor may have an actuation element coupled thereto, and the deploying step may comprise moving the actuation element relative to the retention structure. The retention element may be coupled to a retainer body, and the actuation element may be moved relative to the retainer body to deploy the retention element. During the deploying step the retainer body may remain stationary relative to the base tissue and the actuation element may be refracted proximally relative to the retainer body. The actuation element may be fixed to the first anchor.
The method may further comprise creating a loop with the second extremity, passing at least a portion of the loop around or through the target tissue, and coupling the loop to the first anchor. The loop may be coupled to the first anchor by retaining a free end portion of the second extremity on the first anchor. The free end portion may be retained by passing it through a transverse passage in the first anchor. Retaining the free end portion may comprise clamping the fee end portion between two opposing surfaces of the first anchor. Retaining the free end portion may also comprise passing the free end portion through a loop formed by the second extremity around the bar. The second extremity may form two loops around the bar, and the free end portion is passed through both loops. The free end portion may be retained on the first anchor without tying a knot.
In another aspect of the present invention, a method of securing target tissue to base tissue comprises providing an anchor having a one-way cinching mechanism and a suture pre-threaded through the one-way cinching mechanism. The suture has first and second extremities extending from the anchor. A second extremity is passed through or around the target tissue, and a free end portion of the second extremity is coupled to the anchor to form a repair loop. The anchor is inserted into the base tissue, and the first extremity is tensioned to shorten the loop. The first extremity may be tensioned to shorten the repair loop to a final size without moving the anchor relative to the base tissue. Preferably the step of tensioning the first extremity is performed after the anchor is fully inserted in the base tissue. The one-way cinching mechanism allows the suture to move longitudinally in a first direction when the second extremity is tensioned and inhibits movement thereof in an opposite direction. The suture is locked with the desired degree of tension in the repair loop without requiring the operator to form a knot.
The one-way cinching mechanism preferably comprises a bar coupled to the anchor, the suture being tied around the bar to form a one-way sliding knot or hitch, such as a munter hitch. The hitch may comprise a pole portion and a loop portion formed around the pole portion, wherein tension in the repair loop causes the loop portion to pull transversely on the pole portion to inhibit movement of the suture.
Preferably the anchor is inserted using an insertion tool to which the anchor is releasably coupled, and the method further comprises releasing the anchor from the insertion tool after the step of inserting. The first extremity may be tensioned to increase tension in the repair loop after the step of releasing.
The free end portion of the second extremity is preferably slidably coupled to the anchor to allow adjustment of the size and tension in the repair loop. After the free end portion of the second extremity is coupled to the anchor, the method may further include the steps of tensioning the second extremity to shorten the repair loop to an initial size, and locking the second extremity in position relative to the anchor. The second extremity is preferably locked without forming a knot in the second extremity. The free end portion of the second extremity may be coupled to the anchor in various ways, such as being passed through a transverse channel in the anchor. The second extremity may be locked by means of a clamping or other securing mechanism in the anchor, or by being trapped or compressed between the exterior of the anchor and the surrounding base tissue. Preferably, step of tensioning the first extremity is performed after the step of locking the second extremity.
Usually the final size of the repair loop will be smaller than the initial size. The method may further include a step of holding a predetermined portion of the repair loop as the second extremity is tensioned such that the repair loop may not be shortened beyond the initial size. The predetermined portion may be held within a delivery instrument for the anchor and released after the anchor has been inserted in the base tissue.
In another aspect of the present invention, an anchor for securing target tissue to base tissue comprises an anchor body, and a suture loop coupled to the anchor body. A first suture extremity extends from the anchor body and has a free end portion. The free end portion is passed through the suture loop thereby forming a repair loop outside the anchor body. The suture loop is tightenable to secure the free end portion to the anchor body.
The first suture extremity and the suture loop may be a part of the same continuous suture. The suture loop may comprise a one-way cinching knot allowing the suture to move longitudinally in a first direction and preventing the suture from moving in an opposite direction. The suture may comprise a second suture extremity extending from the one-way cinching knot. The suture may be movable in the first direction when the second suture extremity is tensioned. The anchor may further comprise a bar coupled to the anchor body. The suture loop may be formed around the bar such that the free end portion is passed between the suture loop and the bar and clamped therebetween.
In yet another aspect of the present invention, an anchor for securing target tissue to base tissue comprises an anchor body having a threaded exterior adapted to be screwed into the base tissue, and a suture coupled to the anchor body and having a first extremity with a free end portion. A tip member is rotatably coupled to the anchor body. The tip member has a suture retention structure configured to retain the free end portion such that the first extremity forms a repair loop outside the anchor. The tip member is configured to remain rotationally stationary relative to the base tissue as the anchor body is screwed in.
The tip member may be threadably coupled to the anchor body. The anchor body may have a distal surface configured to engage the free end portion as the anchor body is screwed in. The tip member may be movable relative to the anchor body so as to move the free end portion from a less tortuous configuration to a more tortuous configuration as the anchor is screwed in. The tip member may have a transverse passage through which the free end portion is passed. The suture retention structure may retain the free end portion without a knot therein. The suture retention structure may allow the free end portion to be tensioned to tighten the repair loop. The suture retention structure may allow the suture to be locked relative to the anchor body at any of a plurality of longitudinal positions along the free end portion.
The suture may comprise a second extremity, and the suture may be coupled to the anchor body so as to be longitudinally movable in a first direction when the second extremity is tensioned and to be immovable in a second direction opposite the first direction when the first extremity is tensioned. The anchor may further comprise a one-way cinching mechanism to which the suture is coupled. The one-way cinching mechanism comprises a bar around which the suture is wrapped. The first extremity may be wrapped around the bar and looped around the second extremity to form a U-loop such that tensioning the first extremity causes the U-loop to pull the second extremity in a direction generally tangential to the outer surface of the bar.
In another aspect of the present invention, an anchor for securing target tissue to base tissue comprises an anchor body having proximal and distal ends and threads on an exterior thereof so as to be screwed in to the target tissue. A spool is coupled to the anchor body and is rotatable with the anchor body as it is screwed in. A suture is coupled to the anchor body and has a first extremity with a free end portion, and a suture retention structure is coupled to the anchor body adjacent to the spool and configured to retain the free end portion such that the first extremity is wound around the spool as the anchor is screwed in to the base tissue.
The anchor body may comprise a cylindrical shaft having a first diameter and the spool may comprise a hub having a second diameter substantially smaller than the first diameter. The hub may be disposed between a proximal portion of the shaft and a distal portion of the shaft. The suture retention structure may comprise a transverse passage through the hub. The suture may comprises a second extremity. The suture may be coupled to the anchor body so as to be longitudinally movable in a first direction if the second extremity is tensioned, and inhibited from movement in a second direction opposite the first direction if the first extremity is tensioned. The suture may be coupled to a one-way cinching mechanism in the anchor body. The one-way cinching mechanism may comprise a bar around which the suture is wrapped. The first extremity may wrap around the bar and loop around the second extremity to form a U-loop. The U-loop may pull on the second extremity in a direction generally tangential to an exterior surface of the bar if the first extremity is tensioned.
In still another aspect of the present invention, an anchor for securing target tissue to base tissue comprises an anchor body configured for insertion in the base tissue, and a suture coupled to the anchor body and adapted for coupling to the target tissue. A first retention element is movably coupled to the anchor body, and a second retention element is movably coupled to the anchor body axially spaced from the first retention element. The first and second retention elements are movable from a first configuration having a lower profile suitable for insertion in the base tissue to a second configuration laterally extended from the anchor body to retain the anchor body in the base tissue.
The anchor may further comprise an actuation element coupled to the anchor body and that is movable relative to the first and second retention elements from a first position in which the first and second retention elements are in the first configuration, to a second position in which the first and second retention elements are in the second configuration. The actuation element may comprise at least one camming surface which engages inner surfaces of the first and second retention elements to urge them laterally outward. The retention elements may be coupled to a retainer body. The actuation element may be axially movable relative to the retainer body. The actuation element may be retractable proximally relative to the retainer body. The anchor body may be fixed to the actuation element to move therewith.
The suture may be coupled to a one-way cinching mechanism in the anchor body. The one-way cinching mechanism may allow the suture to move longitudinally in a first direction and inhibit the suture from moving in an opposite direction. The anchor may further comprise a suture retaining structure coupled to the anchor body that is configured to retain a free end portion of the suture. The suture retaining structure may comprise a transverse passage through the anchor body. The suture retaining structure may be movable from a first position in which the free end portion is movable relative to the anchor body to a second position in which the free end portion is fixed relative to the anchor body. The suture retaining structure may move the free end portion from a less tortuous configuration to more tortuous configuration. The anchor may further comprise an actuation element coupled to the anchor body and configured to move the first and second retention elements from the first to the second configuration, wherein moving the actuation element also moves the suture retaining structure. The suture retaining structure may be fixed to the actuation element. The first retention element may be radially offset from the second retention element. The anchor may also comprise a third retention element and a fourth retention element axially spaced apart from the third retention element. The third and fourth retention elements each may be movable from a first configuration having a lower profile suitable for insertion in the base tissue to a second configuration laterally extended from the anchor body to retain the anchor body in the base tissue.
In another aspect of the present invention, an anchor system for securing target tissue to base tissue comprises an anchor for insertion in the base tissue. The anchor has a threaded exterior suitable to allow the anchor to be fully inserted into the base tissue by turning through a first number of rotations. A suture is coupled to the anchor and has at least a first extremity extending therefrom. An insertion tool has a shaft with a distal end. The anchor is removably coupled to the distal end, and the shaft further has a suture winding portion. The first extremity is wound around the suture winding portion a predetermined number of turns correlated with the first number of rotations such that the first extremity is fully unwound from the suture winding portion when the anchor is fully inserted in the base tissue.
The suture may comprise a second extremity that extends from the anchor. The second extremity may not be wound around the suture winding portion of the shaft. The anchor may comprise a suture retaining structure for knotlessly retaining a free end portion of the first extremity. The anchor may further comprise a knotless cinching mechanism through which the suture is threaded. The knotless cinching mechanism may allow the suture to move longitudinally in a first direction and may inhibit the suture from moving in an opposite direction. The shaft may have an inner lumen and the suture winding portion may be on an exterior of the shaft. The shaft may further have an aperture in a side wall thereof through which the first extremity extends from the inner lumen to the suture winding portion. The suture may comprises a second extremity and the second extremity may not extend through the aperture. The second extremity may extend through an inner lumen of the shaft to a proximal end of the shaft. The suture may be longitudinally movable in a first direction when the second extremity is tensioned, but may be inhibited from moving in an opposite direction when the first extremity is tensioned.
In still another aspect of the present invention, an anchor for securing target tissue to base tissue comprises an anchor body, and a first one-way cinching mechanism coupled to the anchor body. The first one-way cinching mechanism is threaded with a suture and allows the suture to move longitudinally in a first direction and prevents the suture from moving in an opposite direction. A suture retention structure is coupled to the anchor body and configured to receive a free end portion of the suture such that the free end portion is longitudinally movable relative to the anchor body and configured to allow the free end portion to be locked relative to the anchor body at any of a plurality of longitudinal positions.
The suture retention structure may comprise a second one-way cinching mechanism configured to allow the free end portion to move longitudinally in one direction and to inhibit movement thereof in an opposite direction. At least one of the first and second one-way cinching mechanisms may comprise a bar coupled to the anchor body, the suture being wrapped around the bar. The suture may comprise first and second extremities. The second extremity may be wrapped around the bar and looped around the first extremity to form a U-loop such that tension on the second extremity causes the U-loop to pull the first extremity in a direction generally tangential to an exterior surface of the bar. The free end portion may be on the second extremity. The suture retention structure may comprise a transverse passage through at least a portion of the anchor body. The suture retention structure may clamp the suture between two opposing surfaces movable relative to each other. The anchor may further comprise a suture retention member movably coupled to the anchor body. The suture retention member may move the suture from a less tortuous configuration to a more tortuous configuration. The suture retention member may be concentrically coupled to the anchor body. The suture retention member may be axially movable relative to the anchor body. The suture retention member may be rotationally coupled to the anchor body. The anchor body may have a threaded exterior configured to be screwed into tissue. The suture retention member may be threadably coupled to the anchor body.
In another aspect of the present invention, an anchor for securing target tissue to base tissue comprises an anchor body, and a first one-way cinching mechanism coupled to the anchor body. The first one-way cinching mechanism is threaded with a first length suture and allows the first length of suture to move longitudinally in a first direction and prevents the first length of suture from moving in a direction opposite the first direction. A second one-way cinching mechanism is coupled to the anchor body. The second one-way cinching mechanism is threaded with a second length of suture and allows the second length of suture to move longitudinally in a second direction and prevents the second length of suture from moving in a direction opposite the second direction.
The first and second lengths may form a single continuous length of suture. The continuous length of suture may form a repair loop between the first one-way cinching mechanism and the second one-way cinching mechanism. The repair loop may be tightened by either moving the first length in the first direction or moving the second length in the second direction.
The first one-way cinching mechanism may comprise a first bar coupled to the anchor body, the first length of suture being tied around the first bar to form a first hitch. The first hitch may include a pole portion and a loop portion looped around the pole portion, wherein when the loop portion is tensioned the loop portion pulls the pole portion transversely to inhibit the first length of suture from moving. The second one-way cinching mechanism may also comprise a second bar coupled to the anchor body, the second length of suture being tied around the second bar to form a second hitch.
The first length of suture may have first and second free ends, and the second length of suture may have third and fourth free ends. A first suture retaining structure may be provided on the anchor body for retaining at least the first free end so as to form a first repair loop in the first length of suture, wherein the second free end is tensionable to tighten the first repair loop. The anchor may further include a second suture retaining structure on the anchor body for retaining the third free end so as to form a second repair loop in the second length of suture, wherein the fourth free end is tensionable to tighten the second repair loop.
The first one-way cinching mechanism may be disposed proximally on the anchor body from the second one-way cinching mechanism. In addition, the first and second one-way cinching mechanisms may be integrally formed with the anchor body.
These and other embodiments are described in further detail in the following description taken together with the appended drawing figures.
FIGS. 28AA-28BB, and 29AA-29BB are side cross-sectional views of suture anchor systems.
FIGS. 34 and 34A-34C are partial side cross-sectional views of a suture anchor system.
FIG. 38F1 is a side-view of a suture anchor.
FIG. 38F2 is a cross-sectional view of the suture anchor in FIG. 38F1.
FIG. 38F3 is a side-view of the suture anchor in FIG. 38F1.
FIG. 38F4 is a cross-sectional view of the suture anchor in FIG. 38F1.
FIG. 38F5 is a side cross-sectional of the suture anchor in FIG. 38F1.
FIGS. 38H1-38H2 are side-views of a suture anchor.
FIGS. 38I1-38I2 are side-views of a suture anchor.
FIGS. 38J1-38J2 are side-views of a suture anchor.
FIGS. 38K1-38K2 are side-views of a suture anchor.
FIGS. 38L1-38L2 are side-views of a suture anchor.
FIGS. 38M1-38M2 are side-views illustrating the use of a suture passer loop to load a repair suture into a suture anchor system.
FIGS. 38M2A-38M2B are perspective and cross-sectional views illustrating the use of a suture passer loop to load a repair suture into a suture anchor system.
FIGS. 38M3-38M5 are side, cross-sectional, and perspective views illustrating the use of a suture passer loop to load a repair suture into a suture anchor system.
Several exemplary embodiments of knotless suture anchors, methods of use and delivery instruments for such anchors are illustrated and described in the attached figures.
When the anchors of the invention are described herein as being “knotless,” this is intended to mean that the anchors allow the operator to cinch the suture to a desired degree of tension and the anchor holds the suture in this position without requiring the operator to tie a knot in the suture. It will be understood that, in some embodiments described herein, specialized one-way sliding knots may be utilized in the anchor to secure the suture to the anchor, but advantageously, these may be pre-tied to the anchors when supplied to the surgeon and need not be tied by the surgeon during the procedure. In some embodiments, specialized anchor threading devices are provided which allow a suture to be tied in such a one-way sliding knot during a procedure, but even in these embodiments, after the suture has been coupled to the target tissue, the surgeon need not tie a knot in the suture to lock it with the desired tension.
Anatomy:
Exemplary use of the devices, systems and methods of the present invention will be discussed primarily in terms of treatment of a hip joint. However, one of skill in the art will appreciate that other tissues may be re-attached to a base tissue or another substrate in other areas of the body including joints such as the shoulder joint, the ankle, wrist and other joints. Other areas may also be treated with the devices, systems and methods disclosed herein. Thus, the exemplary usage described herein is not intended to be limiting.
The labrum L can tear or separate from the acetabular rim due to wear or disease and this can result in pain as well as loss of joint mobility.
Referring now to
The devices, systems and methods of the present invention may also be used for repair of a torn rotator cuff.
Other procedures for reattaching torn tissue to a substrate such as bone include the SLAP repair for a SLAP tear (superior labral tear from anterior to posterior) of a glenoid labrum, as well as the Bankart repair of a shoulder lesion. Any of the suture anchor systems described herein may be used in any of these procedures and in a variety of other procedures where the anchoring of sutures, wires, or other filaments to bone or other tissue is desired. The anchor systems may also be configured for placement in soft tissues and useful in any of various surgical procedures, wherever securing a suture or other filament to tissue may be desired.
Suture Anchor Architectures:
Any of the suture anchors described herein may be fabricated from metals such as stainless steel, nitinol, titanium, etc., ceramics, and other biocompatible materials. However, in preferred embodiments, the anchors are made from MRI (magnetic resonance imaging) compatible polymers such as PEEK (polyetherether ketone) or carbon reinforced PEEK. Dense, hard polymers are preferred so that the anchors will be non-resilient and do not deform when implanted. Preferred embodiments of anchors displace the bone or other substrate tissue when implanted and rely in significant part on the recoil of the substrate tissue against the anchor as well as other mechanical interference mechanisms between the anchor and the tissue to retain the anchor therein. Knotless anchors can also be manufactured by a variety of implantable biodegradable, bioabsorbable or bioresorbable polymers. These polymers are absorbed into the body through biological processes after implantation. Examples of these polymers include polylactide, lactide/glycolide copolymers and lactide/caprolactone copolymers. Each of the above bioabsorbable polymers could also be compounded with bone minerals such as hydroxyapatite or tri-calcium phosphate to create a biocomposite material. Anchors manufactured with these minerals introduce chemicals into the anchor hole which promote the formation of bone as well as a strong bond between the anchor and the bone surface.
In some embodiments, a single suture anchor may be used to reattach torn tissue to a substrate such as bone. For example,
In other embodiments of suture systems, the anchor may include more than one suture anchor positioned in a single hole. For example, an approach for the deployment of suture anchors in an axially stacked arrangement in the same hole is illustrated in
The various suture anchor systems described in detail herein may be configured in a variety of different architectures. These include both one-piece and multi-piece architectures, some of which are illustrated schematically in
In anchoring systems having two or more suture anchors, it may be advantageous to attach the two anchors directly together. This minimizes the possibility that the anchors will become dislodged. For example, in
In some embodiments, a portion of the anchoring system includes a piercing needle for capturing the damaged tissue by passing the suture therethrough.
In addition to the multi-piece architectures described above, the anchor systems of the invention may have various single-piece and other architectures, several embodiments of which are described below.
One-Way Cinching Mechanisms:
In the following detailed description, it will be understood that the term “suture” may include any of various materials used in surgical procedures to repair tissue or to fasten tissues to other tissues or prosthetic structures. These may include not only conventional suture material, but wire, cord, ribbon, tape, fabrics or other flexible filament-like materials. In addition, a suture may be described as entering or exiting an anchor or other structure. It will be appreciated that the terms “enter” and “exit” are relative and therefore a suture that enters an aperture may also be considered to be exiting the aperture. Similarly, a suture that is described as exiting an aperture may be considered to be entering the aperture. The foregoing applies throughout this specification unless indicated to the contrary.
As discussed above, the suture anchor systems described herein preferably include one or more mechanisms for adjusting suture length and tension without requiring the surgeon to tie a knot in the suture.
It will be understood that the term “bar” encompasses a variety of possible structures suitable for wrapping the suture and tying one-way sliding knots according to the invention. The bar may be described as having an axial axis about which the suture is wrapped, and a transverse axis generally perpendicular to the axial axis. The bar may have a cylindrical, oval, race-track, D-shaped or other rounded cross-section, with a curvature or partially rounded surfaces formed around the bar's axial axis to allow the suture to slide easily. The bar may be elongated like a pin, beam or post, with an axial length larger than its transverse width, but may also be short in axial length, just needing sufficient length to accommodate the width of the suture for the desired number of wraps around the bar. The bar may also constitute a portion of material lying between two parallel channels or passages through which the suture may be threaded to form a one-way sliding knot. The bar may be a polymer, metal or other biocompatible material of suitable strength to withstand tensile forces on the suture, and may be molded as an integral part of the anchor, or a separate part that is fixed to the anchor by bonding, welding, press-fit, threads or other suitable connection. The bar may be coupled to the anchor in various orientations, with its axial axis perpendicular, parallel, or at another angle relative to the longitudinal axis of the anchor. As described elsewhere herein, the bar may be mounted to the anchor in various positions, including recessed in a cavity within the anchor, or extending from an exterior surface of the anchor in an elevated configuration.
The cinching mechanism of
Referring to
In the embodiment of
The anchor 6402 has a cylindrically shaped body 6404 with a plurality of scalloped or barbed edges 6406 similar to others previously described. An oval or racetrack shaped central channel 6410 extends longitudinally through the anchor 6402 and an oval shaped bar 6412 extends transversely across the central channel 6410. The distal end 6408 of the upper anchor 6402 is illustrated as having a flat face, but may alternatively have a tapered or pointed distal tip. The top view in
The side cross-section view in
The suture S has a first extremity 6422 that enters a top portion of the central channel 6410 and extends downward into the central channel 6410. The suture S extends partially over top surface 6420 of bar 6412 and downward alongside bar 6412 through the larger space 6416 between the bar 6412 and the inner wall of the central channel 6410. The suture then passes underneath bar 6412 and around lower surface 6418, extending upward alongside bar 6412 through the smaller space 6414. The suture then forms a loop 6426 around the first extremity 6422 and passes back downward through smaller space 6414, looping under bar 6412. A second extremity 6428 then extends upward through the larger space 6416 of central channel 6410 and out of the central channel away from the anchor. As previously described, when the first extremity 6422 of suture is pulled, the suture will move freely and thus can be adjusted. However, when the second extremity is pulled, the looped portion 6426 of suture S will cinch down on the first extremity 6422 creating friction between the two strands of suture and between the suture and the bar, inhibiting suture movement. Further tension may draw loop 6426 and first extremity 6422 into the narrower gap between the bar and the inner sidewall of central channel 6410, thereby preventing the suture from moving. The free end of the second extremity will be wrapped around or passed through the tissue to be repaired, and then coupled to the anchor by means of a second anchor component as described above or by means of a suture retention structure on anchor body 6404 itself. Alternatively the second extremity may be placed into the bone hole prior to anchor placement and trapped between the anchor and the surrounding bone. Advantageously, with the anchor fully inserted into the bone and the second extremity secured, the degree of tension around the tissue may be finely adjusted by pulling on first extremity 6422. The one-way cinching mechanism of the anchor prevents the suture from loosening without the need for the surgeon to tie knots.
FIGS. 28A-28AA, 28B-28BB, 29A-29AA, and 29B-29BB illustrate other anchor system configurations that may use the cinching mechanism of
FIGS. 29A-29AA illustrate another variation of a hitch-type cinching mechanism. In this embodiment, the bar 3106 is inserted substantially parallel to the longitudinal axis of the anchor body, rather than in the transverse direction. FIG. 29AA illustrates a partial cross-section of
In some cases it may be advantageous for the suture anchor to include two or more one-way cinching mechanisms. These may be threaded with two or more separate sutures so that more than one suture may be attached to the same anchor. Alternatively, a pair of one-way cinching mechanisms on the anchor may be threaded with opposing ends of the same length of suture so as to be able to adjust suture tension by pulling either or both of the two ends of the suture.
Each of sutures S1, S2 has a first extremity S1A, S2A which can be pulled to slide the suture around the respective upper and lower bars 8084, 8085, allowing adjustment of suture tension. The other extremities S1B, S2B may be passed around or through the tissue to be repaired and then placed through the transverse channel 8089 to form two repair loops RL1, RL2. The free ends of extremities S1B, S2B may be pulled to adjust the size of and tension in the repair loops prior to anchor insertion. The anchor may then be inserted into the base tissue, trapping extremities S1B, S2B between the bone and the anchor to lock them in place. Following anchor insertion, extremities S1A, S2A may be tensioned to adjust repair loops RL1, RL2 to their final size and tension. In this manner, multiple sutures may be coupled to a single anchor and independently adjusted. It should be noted that while anchor 8080 is illustrated with two bars 8084, 8085 to accommodate two sutures, anchor 8080 may include three, four or more such bars to allow three, four or more independently adjustable sutures to be coupled to a single anchor. With a simple, unitary, moldable construction without moving parts, the one-way cinching mechanism in the anchors of the invention can be manufactured at very small scale to facilitate this multi-suture capability.
In addition to facilitating more even adjustment of suture length and tension, a double hitch-type cinching mechanism allows increases in the strength of the repair resulting from the anchoring system. In the embodiment illustrated in
The hitch-type cinching mechanism may also be used to form the double row bridge suture used to repair torn rotator cuffs and illustrated in
Repair sutures 3726, 3728 (which may comprise separate lengths of suture or a single continuous length of suture for passing through or around tissue to be repaired) are received under the strangling element 3710, in between the bight 3712 and then looped over the strangling element 3710 and back through the bight 3712 in the opposite direction. The repair sutures 3726, 3728 may be sutures received from one or more adjacent suture anchors, or the sutures may be secured to anchor 3702 and then extend to other suture anchors, to form, for example, a double row bridge for repairing a torn rotator cuff. Alternatively, repair sutures 3726, 3728 may comprise the two ends of a single continuous length of suture which is passed through or around tissue to be repaired, or is coupled to another anchor or other structure. Anchor 3702 may first be driven into the bone or other base tissue before repair sutures 3726, 3728 are coupled to the anchor or the locking suture S. The repair sutures 3726, 3728 may then be passed through the bight 3712 and pulled to grossly adjust the position of the tissue being repaired and the tension of the repair sutures. The free end 3722 of suture S may then be pulled, thereby drawing the strangling element 3710 and the bight 3712 into the central channel 3718 of the anchor 3702. Length and tension of the locking suture S is further adjusted until the bight 3712 is pulled tight against strangling element 3710, thereby clamping the repair sutures 3726, 3728 therein. The strangling element 3710 is free to slide along the length of suture S, which may be tightened to pull the strangling element to the desired depth within the central channel 3718 to finely adjust the tension in repair sutures 3726, 3728. The hitch-type knot around bar 3708 prevents the suture from moving in the reverse direction so that bight 3712 remains tight. This embodiment thus has the advantage of allowing the repair suture to be coupled to the target tissue while the suture is unattached to the anchor, and of allowing the anchor to be inserted without being attached to the repair suture, giving the operator maximum flexibility and ease of use. Further this anchor system allows the repair suture to be coupled to the anchor by the operator in situ with the anchor in its final implanted position. This contrasts conventional knotless anchors which require the repair suture to be pre-threaded through the anchor outside the body cavity and require the repair suture to be fastened to the target tissue while the suture is coupled to the anchor.
In preferred embodiments, the hitch-type knots used to form the one-way cinching mechanisms of the invention will be pre-tied within the anchor so that the physician need not tie any further knots during the procedure in order to repair the target tissue. However, in some cases physicians may desire to perform a procedure with the suture initially decoupled from the anchor and to later tie the suture to the anchor during the procedure.
In alternative embodiments, a double helical thread may be used in order to facilitate threading into bone. In still other embodiments, the diameter of the double start screw may be tapered from the proximal to the distal end. This allows the screw to be advanced halfway into a hole in bone without pressure or rotation, and can therefore be screwed completely into the hole with half as many turns.
Suture Free End Coupling Mechanisms:
Socket 3814 has an inwardly extending flange around its proximal end to retain the head 3812 therein. Thus, as the upper anchor is threadably engaged with bone or other tissue, the lower anchor will remain stationary, preventing the suture coupled thereto from tangling.
FIGS. 38F1-38F5 illustrate still another embodiment of a suture anchor having a one-way cinching mechanism and threads for securing the anchor into tissue. FIG. 38F1 illustrates a distal region of the anchor 4802 having a generally cylindrically shaped body 4804 and threads 4806 for securing the anchor into bone or other substrate tissue. A transverse pin or bar 4808 extends through the anchor and is used to form the one-way cinching mechanism therearound. The distal portion of the anchor includes a tapered tip 4810 rotatably coupled to the anchor body 4804 via neck region 4814. A transverse channel 4812 extends through the tapered tip and allows suture to be secured to the anchor or to be passed therethrough. FIG. 38F3 illustrates anchor 4802 rotated approximately 90 degrees. FIG. 38F2 illustrates a cross section taken along line B-B in FIG. 38F3 and illustrates the square shaped central channel 4818 that extends through the anchor body. FIG. 38F4 illustrates a cross section taken along line C-C in FIG. 38F3 and illustrates the triangular drive hole 4820 on the proximal end of the anchor that cooperates with a similarly shaped driver tool for threading the anchor into the bone. FIG. 38F5 is a cross section taken along line A-A in FIG. 38F3 and illustrates how the suture S passes through the anchor forming a hitch-style cinching mechanism 4816 similar to those previously discussed above. Additionally, FIG. 38F5 shows how the tapered tip 4810 is coupled to neck 4814 which extends into the central channel 4818 of the anchor. This allows the tapered tip 4810 to remain stationary relative to the bone while the anchor body 4804 is screwed into the bone, preventing the free end of the suture S (not shown) placed through channel 4812 from becoming wrapped around the body of the anchor.
It should be noted that the rotatable tips disclosed in
In some embodiments, the suture may be wrapped around or spooled on a part of the anchor as the anchor is threaded into the bone. For example,
FIGS. 38H1-38H2, 38I1-38I2, 38J1-38J2, 38K1-38K2, and 38L1-38L2 illustrate further embodiments of rotatable couplings between the lower anchor tip and the proximal anchor body and structures for securing a free end of the suture, any of which may be used in the anchor of
FIGS. 38J1-38J2 illustrate the lower anchor portion 3850b includes a tapered distal tip 3852b and a central channel 3856b having threads 3854b and a transverse channel 3862b through the sidewall of the anchor. The upper anchor portion 3858b has a lower distal threaded portion 3860b that threads into central channel 3856b. The suture S is threaded through the transverse channel 3862b so that when the upper anchor portion 3858b is threaded into the central channel 3856b, the suture S will be compressed between the inner and outer anchors along the sides of the distal threaded portion 3860b and, optionally at the bottom of the central channel, as illustrated in FIG. 38J2.
In another variation, FIGS. 38K1-38K2 illustrate another embodiment where the suture is pinched between the upper and lower anchors. The lower anchor 3850c includes a tapered distal tip 3852c, a central channel 3856c which is partially threaded 3854c and has a transverse channel 3862c extending through the sidewalls of the anchor below the threaded portion of the central channel. The upper anchor portion 3858c has a distal threaded portion 3860c. The suture S is threaded through the transverse channel 3862c and thus when the upper anchor portion 3858c is threaded into the central channel 3856c, the suture will be pressed downward until it is pinched between the distal tip of the threaded portion 3860c and the bottom of the central channel 3856c, as shown in FIG. 38K2.
FIGS. 38L1-38L2 show another variation where the suture is pinched between the upper and lower anchor portions. The lower anchor 3850d includes a tapered distal tip 3852d and a proximal threaded portion 3851 having a transverse channel 3862d therethrough. The upper anchor 3858d includes a central channel 3859 at its distal end having threads 3860d for engaging the proximal threaded portion 3851 of the lower anchor 3850d. In use, the suture S is threaded through the transverse channel 3862d and the upper and lower anchors 3858d, 3850d are threadably engaged together. This forces the suture up into the central channel 3859 where it becomes compressed between the upper and lower anchors along the sidewalls of proximal threaded portion 3851, as seen in FIG. 38L2.
FIGS. 38M1-38M2 illustrate an alternative mechanism for attaching the free end of the repair suture to the anchor. FIGS. 38M3-38M5 illustrate side, cross-sectional and oblique views of the device of FIG. 38M1 mounted on an anchor insertion tool, highlighting the suture passer loop. The anchor system includes a tubular upper anchor portion 3870 slidably or threadably coupled to a lower anchor portion 3876 having a one-way cinching mechanism as elsewhere described herein, and a transverse channel 3874 near a distal end thereof. A suture passer loop 3872 is pre-threaded through the upper anchor 3870 and through the transverse channel 3874 in lower anchor 3876. The loop 3878 is then fed back through the upper anchor 3870. Initially, the upper anchor portion is retracted proximally relative to the lower anchor portion, allowing suture passer loop 3872 to slide between the two. After capturing the target tissue with the repair suture, the free end of the repair suture 3880 is fed through the loop 3878 so that when the passer loop 3872 is pulled back the free end of the repair suture will be pulled through the upper anchor, through the transverse channel and back up through the upper anchor. FIG. 38M2A shows the repair suture 3880 coupled with the anchor once the suture passer loop 3872 has been removed, and FIG. 38M2B is a cross-section of FIG. 38M2A showing an internal view of the suture threaded through the anchor. When the desired length and tension have been imparted to the repair suture loop, the upper anchor portion is advanced distally relative to the lower anchor portion by sliding or screwing them together, compressing the free end of the repair suture between the upper and lower anchor portions, locking the suture in position. The free end may then be trimmed or be coupled to another suture anchor. The other free end of the suture may then be pulled for additional tensioning of the repair loop via the one-way cinching mechanism.
Another mechanism for securing the free end of a repair suture to the suture anchor is illustrated in
It should be understood that any of the one-way cinching mechanisms or the mechanisms for securing the free end of the repair suture described in the context of any particular embodiment herein may also be used in any other of the anchor embodiments disclosed.
Anchoring Features:
The suture anchors disclosed herein may be anchored to substrate tissue such as bone by a number of means. As described above, the anchor may be threaded or press fit into a hole in the substrate tissue. Surface features such as barbs, ribs, or threads may be disposed on the anchor's exterior to help to secure the anchor into the tissue. Alternatively, the anchors of the invention may have separate bone-engaging mechanisms which are operable independently of the insertion of the anchor into the bone such that the anchor may be first inserted, then secured in a separate step. In anchor systems having two or more anchor components, the anchor components may interact with one another in order to help lodge them in the bone. For example, in
Although not illustrated, it will be understood that any of the embodiments of the suture anchors of the invention described herein may include features on the exterior thereof to enhance retention of the anchor in bone or other tissue, or to promote tissue ingrowth into the anchor. Such features may comprise bumps, divots, barbs, ridges, axial or circumferential ribs, threads, scales, flaring wings, projections, concave regions, or other structures to enhance friction or to mechanically engage the surrounding bone or tissue and resist proximal movement of the anchor after it has been fully inserted. Such features are well-known in the art, with examples illustrated in U.S. Pat. Nos. 6,554,852, 6,986,781, and 6,007,566, which are incorporated herein by reference.
Delivery Instruments:
Referring to
In use, repair end 9548 of suture S is first passed around or through the tissue to be repaired and then through loop 9554 in suture snare 9553. The ends 9556 of suture snare 9553 may then be pulled by the operator to draw the repair end 9548 through transverse channel 9555 in anchor 9533. By continuing to pull the suture snare, the repair end 9548 may be drawn into shaft 9531 and the repair loop formed by repair end 9548 through the target tissue may be shortened to an initial size and degree of tension. Advantageously, the slack retention suture 9550 maintains slack loop 9549 to ensure that the repair loop is not excessively shortened prior to anchor placement. Delivery instrument 9530 is then manipulated to insert anchor 9533 into the bone or other base tissue, trapping the free end of repair end 9548 between the bone and the anchor to lock its position relative to the anchor. After insertion of the anchor to its final implanted position, thumbscrew 9544 may be loosened, releasing adjustment end 9547 of suture S and first end 9551 of slack retention suture 9550. Pull tab 9545 is then withdrawn from hole 9546 and retracted to pull slack retention suture 9550 out of delivery instrument 9530, thus releasing slack loop 9549. Adjustment end 9547 of suture S may then be pulled to further shorten the repair loop through the target tissue and to apply the desired degree of final tension. Shaft 9531 is then decoupled from anchor 9533 and withdrawn from the surgical site, and the adjustment and repair ends of suture S trimmed as needed, completing the repair.
The anchor systems of the invention may further include a suture threading device to allow the suture to be threaded through the one-way cinching mechanism of the anchor during a surgical procedure. In this way the anchor and suture may be supplied initially separated from each other, and the physician may place the suture through the target tissue to be repaired before it is coupled to the anchor, giving him/her maximum flexibility in the type and location of stitches used. Once these stitches are placed, the physician may use the suture threading device to thread the suture through the one-way mechanism of the anchor, and the anchor may then be placed in the substrate tissue.
As shown in
Anchor 9802 may be any of the embodiments described above, preferably being an embodiment in which one or more bars are contained within a cavity which opens on a sidewall of the anchor, like that shown in
It will also be understood that while the routing pins 9807a, 9807b, 9807c are illustrated as being fixed to the package 9801 for the anchor system of the invention, the routing pins could alternatively be part of a structure detachably coupled to the distal end of delivery instrument 9803 or to anchor 9802. As a further alternative, structures like these routing pins could be integrated into anchor 9802 itself, either being implanted with the anchor, or decoupled therefrom once the suture has been threaded.
In use, suture 9804 is first passed into the body cavity and placed around or through the target tissue to be repaired. The ends of suture 9804 are then drawn back out of the body cavity and the end 9815 which is to become the tensioning end is passed through bight 9810 as shown in
A further embodiment of an anchor system which can be threaded intraoperatively is illustrated in
Inner suture retention component 9853 has an axial shank 9856 with a bifurcated arrowhead-shaped tip 9857. The opposing halves of arrowhead tip 9857 are resiliently deflectable inwards toward each other. The proximal edge 9857A of the arrowhead tip has a transverse dimension larger than the width of longitudinal channel 9855 such that upon insertion into channel 9855, the opposing halves of arrowhead tip 9857 deflect inwardly until they pass beyond the distal tip of outer anchoring component 9852, whereupon they spring back to their original configuration. The proximal edge 9857A of arrowhead tip 9857 engages the distal end of anchoring component 9852, locking the inner suture retention component 9853 to the outer anchoring component 9852.
Shank 9856 has a transverse channel 9858 extending through a mid-portion thereof. A bar 9859 is mounted within channel 9858 to as to have gaps along its proximal and distal sides through which a suture may be threaded. In this way a suture S may be tied around the bar to form a one-way sliding knot as described elsewhere herein. A pair of longitudinal channels 9860 extend on opposite sides of shank 9856 from its proximal end distally until they intersect with transverse channel 9858. These channels are configured to slidably receive the two extremities of suture S extending from bar 9859 when the inner suture retention member 9853 is locked within the outer anchoring component 9852. A transverse slot 9862 which opens at the distal tip of inner suture retention member 9853 bifurcates arrowhead tip 9857 and further serves as a means to retain a free end of suture S when the inner suture retention member is inserted in the outer anchoring component, as shown in
In use, the outer anchoring component 9852 is driven into the base tissue, either by screwing, pounding or pressing. In some cases a hole will first be pre-drilled into the bone, although outer anchoring component 9852 may be self tapping to avoid the need for pre-drilling. The suture is initially decoupled from the inner suture retention component, and may be passed through or around the target tissue independently of the anchor. Suture S is then threaded through inner suture retention component 9853 to form the one-way sliding knot described above, using a threading device like that described above in connection with
Suture Marking Features:
In some situations, it may be advantageous to identify different portions of the repair suture in order to facilitate suture manipulation during a repair procedure such as when positioning the anchor 7102 into a hole 7114 in bone 7116. For example, in minimally invasive procedures where the surgical field is small, or in procedures where blood obstructs viewing the suture, it may be difficult to identify which end of the suture can be adjusted.
While the above detailed description and figures are a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. The various features of the embodiments disclosed herein may be combined or substituted with one another. Therefore, the above description should not be taken as limiting in scope of the invention which is defined by the appended claims.
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| Number | Date | Country | |
|---|---|---|---|
| 20100292732 A1 | Nov 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61304352 | Feb 2010 | US | |
| 61298780 | Jan 2010 | US | |
| 61263728 | Nov 2009 | US | |
| 61263751 | Nov 2009 | US | |
| 61219290 | Jun 2009 | US | |
| 61177602 | May 2009 | US |
